Merck &amp; Its HPV Vaccine: Sales &amp; Skepticism Are Both Up

For the past seven years, a drumbeat of publicity and warnings were issued over the virtues of the human papillomavirus, or HPV, and how to thwart its spread before countless women develop cervical cancer. The impetus was FDA approval of Gardasil, the Merck vaccine, for treating girls and women between the ages of 13 and 21.

But Gardasil was a hard sell, even though Merck launched a big promotional push. Beyond generalized concerns over vaccine safety, a hot-button controversy at the time, there were also some parents and social conservatives who worried that vaccination might be seen as a green light by teenage girls to have premarital sex.

Of course, Merck made matters worse with a sneaky campaign to have Gardasil listed on mandatory vaccinations across the country. Public health officials had recommended vaccination, but the drugmaker lost credibility over its surreptitious effort to woo state legislators. Remember, this occurred just two years after the scandal over the safety of the withdrawn Vioxx painkiller.

By now, however, such problems should have been in the past, especially given the ongoing concerns expressed by public health officials that mitigating the threat of cervical cancer can be best accomplished by vaccination. Besides Gardasil, another choice is Cervarix, which is marketed by GlaxoSmithKline.

But a recent study found more parents are refusing to have their girls vaccinated against HPV than ever before. Five years ago, 40 percent of parents surveyed said they would not vaccinate their girls against HPV. In 2009, that rose to 41 percent and climbed to 44 percent in 2010. And parents concerned about side effects rose from 5 percent in 2008 to 16 percent in 2010.

The study, which was published in Pediatrics, analyzed vaccination data for teens between the ages of 13 and 17 in the 2008-2010 National Immunization Survey of Teens. As of 2010, about one-third of girls had an HPV vaccine, although this was up from 16 percent in 2008. Still, eight of 10 had the Tdap vaccine for tetanus, diphtheria and pertussis, while 63 percent had the MCV4 meningococcal vaccine.

Why is HPV vaccination a sore spot? A lack of knowledge or a belief that vaccination is unnecessary; vaccination was not recommended by a physician; the vaccines are inappropriate for their child’s age; ongoing concerns remain over safety and side effects, and parents who say their child is not sexually active. These are familiar refrains, but obviously remain tough obstacles for the drugmakers.

“When will people realize there is a huge difference between ‘increasingly concerned about the safety’ and ‘increasingly aware of the potential risks’? After all, this would not be the first time a prescription medication approved by the FDA as ‘safe and effective’ turned out to be nothing of the sort. Will HPV vaccines be next?” asks Norma Erickson of SaneVax, an advocacy group opposed to the vaccnes.

Just the same, Gardasil sales were strong last year, hitting $1.6 billion, a 65 percent rise from 2010. However, that was also the first full year after the FDA approved the vaccine for preventing warts caused by certain strains of the HPV in boys and men. Meanwhile, Merck cut back on consumer advertising. Last year, the drugmaker spent just shy of $44 million to promote Gardasil, a far cry from the $59 million spent in 2009 and nearly $93 million in 2008, according to Nielsen. For its part, Glaxo spent absolutely nothing and its sales dropped 46 percent last year to $408 million.

Of course, public health officials would like to see more aggressive promotion if that would spur vaccinations, but it is unclear if this will occur. A Glaxo spokesman did not respond to questioning and a Merck spokeswoman would only say that existing promotions will continue through this year, but there is no plan to resume television advertising that ended in 2009.

Both drugmakers could use a pick-me-up for their bottom lines, but obviously will have to find a message that can convince skeptics that their vaccines are safe and effective. As the survey indicates, this will not be easy. Parental trust can be a tough commodity to come by in the pharmaceutical industry.

I've followed the pharmaceutical industry since 1995. This ride began at The Star-Ledger of New Jersey and continues with Pharmalot, which I have run since 2007. Along the way, I was also an editor at The Pink Sheet. Before covering pharma, I worked for several years at New ...